An interventional study of posterior percutaneous pedicle screw internal fixation in Vertebral Fracture, sponsored by 153rd Hospital of Chinese People's Liberation Army. Completed. Open to participants aged 25 Years to 47 Years. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by 153rd Hospital of Chinese People's Liberation Army · Not applicable, Interventional, and Treatment
To validate the safety and effectiveness of minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.
History and current related studies Thoracolumbar spinal fractures are frequently seen after trauma because of the biomechanical transitional junction of this structure. The primary treatment method used for traumatic thoracolumbar spinal fracture is posterior pedicle screw fixation, but this method has some disadvantages including severe trauma, extensive bleeding, long rehabilitation time, and long postoperative duration of intractable lumbar stiffness and low back pain. These complications occur mainly because of wide stripping and injury of the paraspinal muscles and peri-articular denervation. Percutaneous pedicle screw external fixation of spine fracture can reduce injury caused by screw insertion into the paraspinal muscles, particularly in the treatment of acute thoracolumbar vertebral compression fracture with simple anterior spinal column injury.
Adverse events We recorded possible adverse events, including wound pain, infection, back muscle pain, spinal cord/nerve injury, screw pull-out, or screw loosening. If severe adverse events occurred, details including the data of occurrence and measures taken to treat the adverse events were reported to the principle investigator and the institutional review board within 24 hours.
Possible biases and management measures Possible biases
Statistical analysis Statistical analysis was performed by a statistician using SPSS 19.0 software (IBM, Amrok, USA), and was conducted following the intention-to-treat principle. Normally distributed measurement data were expressed as the mean ± SD, and minimums and maximums. Non-normally distributed measurement data were expressed as lower quartile (q1), and median and upper quartile (q3). The Wilcoxon matched-pairs signed-ranks test was performed for comparison of the Cobb angle before surgery with the Cobb angle 3 years after surgery, and the McNemar's chi-squared test was used to compare the incidence of adverse reactions. The significance level was α = 0.05.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 32 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with 153rd Hospital of Chinese People's Liberation Army as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation.
Procedure: posterior percutaneous pedicle screw internal fixation
The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.
The Cobb angle of the injured vertebral body
To investigate the change in the thoracolumbar spine curvature. A greater Cobb angle indicates more severe kyphosis.
Time frame: before, immediately after, and 3 months after surgery
Anterior height of the injured vertebral body
To evaluate the morphological recovery of the thoracolumbar spine. A smaller anterior height of the injured vertebral body indicates less severe injury to the vertebral body.
Time frame: before, immediately after, and 3 months after surgery
X-ray
Time frame: before, immediately after, and 3 months after surgery
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.